THERMOCOOL SMARTTOUCH SF D134701Recalls & reported problems

Summary

The FDA's MAUDE database contains 278 adverse event reports that list this exact device (DI 10846835009774), received between Jan 6, 2017 and May 26, 2026 — classified as 11 deaths, 166 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (118 reports).

8 other recalls cover devices cleared under the same FDA submission (P030031); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 278 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, THERE WAS A PROBLEM WITH THE FORCE OF THE CATHETER. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE CUSTOMER'S REPORTED FORCE ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON (B)(6) 2026, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE IN THE PEBAX AND A REDDISH MATERIAL INSIDE THE PEBAX. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF A ¿HOLE¿ IN THE PEBAX AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25291441 ↗
• MalfunctionApr 17, 2026Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND THERE WAS COAGULATION IN FRONT OF THE THIRD ELECTRODE. THE MEDICAL TEAM WAS UNABLE TO REMOVE A SINGLE COAGULATION THREAD FROM THE DEVICE. THE SYSTEM DID NOT DISPLAY ANY ERROR MESSAGES. THE DOCTOR DISCOVERED THE COAGULATION WHEN HE WANTED TO REINSERT THE CATHETER, BUT HE DID NOT USE THE CATHETER ANY FURTHER SINCE HE WAS UNABLE TO REMOVE THE COAGULATE THAT WAS ALREADY ON IT. THE AVERAGE CATHETER FORCE DID NOT EXCEED 25 GRAMS OR 40 GRAMS FOR ANY EXTENDED PERIODS OF TIME. THE IRRIGATION RATE WAS WITHIN THE PRESCRIBED PARAMETERS (POWER UP TO 30 W, HIGH FLOW RATE OF 8 ML/MIN; 31 W OR GREATER, HIGH FLOW RATE OF 15 ML/MIN; VARIPULSE CATHETER HIGH FLOW RATE 30ML/MIN; STSF DE: PF ABLATION FLOW RATE OF 4 ML/MIN). HEPARINIZED NORMAL SALINE HAD BEEN USED AT HE IRRIGATION FLUID. THE FOLLOWING CARTO VISITAG PARAMETERS WERE USED: RESPIRATION SETTING, STABILITY RANGE, STABILITY TIME, FORCE OVER TIME, & TAG SIZE. 3MM, 3SEC, 25% & 3. NO FURTHER DETAILS WERE PROVIDED REGARDING COMPLETION OF THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916776 ↗
• InjuryMar 30, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA (AT) PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS AND DRAIN PLACEMENT. IMMEDIATELY AFTER THE AT PROCEDURE WITH THERMOCOOL SMARTTOUCH SF CATHETER, THE BLOOD PRESSURE DECREASED. TRANSTHORACIC ECHOCARDIOGRAPHY CONFIRMED ACCUMULATION OF PERICARDIAL FLUID/CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED AND BLOOD PRESSURE NORMALIZED. THE PATIENT LEFT THE ROOM AND RETURNED TO THE WARD, AND FURTHER COURSES WILL BE FOLLOWED LATER. THE PHYSICIAN¿S ASSESSMENT OF HEALTH HAZARD WAS NON-SERIOUS (MODERATE/MINOR), NO EXTENSION OF HOSPITALIZATION NOTED. THE PHYSICIAN¿S COMMENT ON RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT NO RELATIONSHIP IS CONSIDERED. THE EVENT MAY HAVE OCCURRED WHILE MANIPULATING ANOTHER COMPANY¿S CATHETER THAT HAD BEEN PLACED IN RV. THE CF MONITORING METHODS WERE DASHBOARD AND VECTOR. THE VISITAG COLORING SETTING WAS TAG INDEX, AND ADDITIONAL VISITAG FILTER USED WAS FOT. NO ABNORMALITIES WERE OBSERVED PRIOR/DURING PRODUCT USE. THE OUTCOME OF THE ADVERSE EVENT WAS IMPROVED. ONE CATHETER WAS USED FOR EACH EXCHANGE. THE ENERGY US

  Patient problems: Cardiac Tamponade

  MAUDE report 24737485 ↗
• InjuryMar 26, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A THERMOCOOL SMARTTOUCH CATHETER AND THE PATIENT EXPERIENCED A STROKE. A PATIENT WHO HAD A PVI (PULMONARY VEIN ISOLATION) ABLATION PROCEDURE ON (B)(6) HAD A STROKE ON (B)(6). THE PROCEDURE WAS INITIALLY MAPPED WITH VARIPULSE, BUT DUE TO THE LA (LEFT ATRIUM) ANATOMY THE PHYSICIAN DECIDED TO CONTINUE MAPPING WITH PENTARAY AND DO THE ABLATION WITH STSF CATHETER. NO ABLATION WITH VARIPULSE WAS PERFORMED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS PATIENT CONDITION. PROCEDURAL ACT (ACTIVATED CLOTTING TIME) WAS >300. THERE WAS NO EVIDENCE OF THROMBUS/CLOT/CHAR DURING THE PROCEDURE. IT WAS REPORTED THAT PATIENT HAD A SYMPTOMATIC STROKE AND THE SYMPTOMS ARE ONGOING. PATIENT REQUIRED EXTENDED HOSPITALIZATION. THE PATIENT DOES NOT HAVE HISTORY OF PREVIOUS STROKE.

  Patient problems: Stroke/CVA

  MAUDE report 24702167 ↗
• DeathMar 20, 2026Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT ATRIAL FLUTTER (L-AFL) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS, SURGICAL REPAIR, ECMO AND HEMODIALYSIS. ULTIMATELY THE PATIENT DIED. DURING ABLATION A STEAM POP OCCURRED USING 35 WATTS AND A CONTACT FORCE OF 43G AT THE POINT IN QUESTION. THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. PATIENT REQUIRED A PERICARDIAL PUNCTURE AND REINFUSION BUT THE PERICARDIAL EFFUSION DID NOT RESOLVE ON ITS OWN AND THEREFORE THE PATIENT WAS TRANSPORTED TO ANOTHER HOSPITAL (UNIVERSITÄTSKLINIKUM FRANKFURT) FOR THORACOTOMY AND THEY FOUND RIGHT VENTRICLE (RV) PERFORATION AND IT WAS REPAIRED SURGICALLY. THE PATIENT'S CONDITION WORSENED AND THE PATIENT WAS ON ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) AND HEMODIALYSIS. THE PATIENT BECAME SEPTIC 1 WEEK POST EVENT. THEN IT WAS REPORTED THAT THE PATIENT DIED. THE PHYSICIAN'S OPINION ON THE ADVERSE EVENT WAS THAT FORCE WAS TOO HIGH DURING ABLATION AND PERFORATION WAS FOUND IN THE RV. IT WAS REPORTED THAT THERE WAS A SMALL NOT AUDIBLE STEAM POP IN LEFT ATRIUM (LA) ANTERIOR WALL THAT COULD CORRELATE WITH PERICARDIAL EFFUSIO

  Patient problems: Cardiac Perforation; Cardiogenic Shock; Hemorrhage/Blood Loss/Bleeding; Sepsis

  MAUDE report 24656444 ↗
• DeathMar 19, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A CARDIAC INDEX ABLATION FOR VENTRICULAR TACHYCARDIA (VT) ON (B)(6) 2026. IT WAS REPORTED THAT DEATH, CAUSED BY CARDIOGENIC SHOCK AFTER ELECTRICAL STORM (AE#1). IT OCCURRED APPROXIMATELY 14 DAYS AFTER CARDIAC ABLATION WITH THERMOCOOL SMARTTOUCH SF CATHETER, CATEGORIZED WITH SEVERITY OF SEVERE AND SERIOUS, WITH DEATH, LIFE-THREATENING ILLNESS OR INJURY. AND IN-PATIENT OR PROLONGED HOSPITALIZATION WITH AN ADMISSION DATE OF (B)(6) 2026 AND DISCHARGED DATE OF (B)(6) 2026 REQUIRING MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. THE RELATIONSHIP WITH THE ABLATION CATHETER AND OTHER DEVICES IS NOT RELATED. THE RELATIONSHIP WITH THE INDEX STUDY PROCEDURE IS NOT RELATED AND N/A (DOES NOT MEET ABOVE CRITERIA). THE OUTCOME IS DEATH WITH DATE OF DEATH ON (B)(6) 2026 ACCORDING TO DEATH FORM. CATECHOLAMINES, CARDIOVERSION AND OTHER RESUSCITATION MEASURES WERE PROVIDED TO THE PATIENT. THE DATE THE EVENT WAS FIRST REPORTED TO BE A SERIOUS ADVERSE EVENT (SAE) WAS (B)(6) 2026.

  Patient problems: Cardiac Arrest; Cardiogenic Shock; Tachycardia

  MAUDE report 24643565 ↗
• InjuryFeb 20, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF (STSF) CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE WHICH REQUIRED PROLONGED HOSPITALIZATION. THE REPORT INDICATED THAT DURING ABLATION WITH A THERMOCOOL SMARTTOUCH SF CATHETER, A STEAM POP WAS NOTED DURING ABLATION WITH 50W. AFTER A FEW MINUTES, THE SYSTOLE DROPPED TO 50, AND ECHO CONFIRMED A PERICARDIAL EFFUSION (PE). THE PHYSICIAN STOPPED THE PROCEDURE. FLUID WAS DRAINED AND THE PATIENT WAS THEN TAKEN INTO INTENSIVE CARE AND WAS STABLE BEFORE AND UPON TRANSFER, SYSTOLIC PRESSURE WAS FINE AS WELL. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS TOO MUCH FORCE AND ¿HEAT FROM HIS SIDE¿. THE PATIENT FULLY RECOVERED (NO RESIDUAL EFFECTS). THE SHEATH AND THE CATHETERS EXCHANGE WERE APPROXIMATED 6-7 TIMES. NO TRANSSEPTAL PUNCTURE SITE WAS PERFORMED DURING THE PROCEDURE. TWO ABLATIONS WERE PERFORMED DURING THE PROCEDURE WITH RADIOFREQUENCY (RF) ENERGY IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT), OUTSIDE THE PULMONARY VEINS. THERE WERE NO ABLATIONS PERFORMED WITHIN THE PULMONARY VEINS. THE FORCE SENSING ABLATION CAT

  Patient problems: Cardiac Tamponade

  MAUDE report 24402967 ↗
• MalfunctionFeb 12, 2026Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings; Detachment of Device or Device Component; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION AFIB ¿ PERSISTENT ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF (STSF) AND THE CATHETER END WAS PULLED OUT LEAVING ITS WIRES EXPOSED. THE REPORT INDICATED THAT THE PATIENT WAS PREPPED AND DRAPED IN NORMAL FASHION. THE STSF ABLATION CATHETER WAS ADVANCED INTO THE PATIENT AS NORMAL, AND A FAST ANATOMICAL MAPPING (FAM) OF THE RIGHT ATRIUM WAS CREATED. THE TRANSEPTAL PUNCTURE WAS PERFORMED AND THE STSF WAS ADVANCED INTO THE LEFT ATRIUM WHERE IT WAS ZEROED APPROPRIATELY. UPON ABLATION, THERE WERE EXTREMELY HIGH FORCE READINGS. UPON RE ZEROING, THE CATHETER FUNCTIONED AS NORMAL WHILE DELIVERING MORE ABLATIONS. THEN, DURING ONE ABLATION, THE CATHETER DISAPPEARED OFF THE SCREEN AND THEN APPEARED IN A DIFFERENT LOCATION. IT DID RESOLVE AFTER A FEW SECONDS AND RETURNED TO ITS ACCURATE POSITION. FORCE SENSOR ERROR THEN APPEARED ON CARTO. AFTER UNPLUGGING AND RE-PLUGGING THE ERROR PERSISTED. THEN, AS THE PHYSICIAN DISCONNECTED THE CATHETER FROM THE CABLE, THE CATHETER END WAS PULLED OUT LEAVING ITS WIRES EXPOSED AND THE CABLE STILL CONNECTED. AFTER DISCONNECTING THE CATHETER AND REPLACING IT WITH A NEW ONE, THE ERROR WAS RESO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320399 ↗
• InjuryFeb 3, 2026Patient Device Interaction Problem

  DURING CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION/CARDIAC TAMPONADE TREATED WITH DRAINAGE AND REQUIRING EXTENDED HOSPITALIZATION. INITIALLY, THE REPORT INDICATED THAT THE QDOT MICRO CATHETER (TWO CATHETERS FROM THE SAME LOT) DISPLAYED ERROR 106 IMMEDIATELY AFTER CONNECTION PRE-OP. THE MEDICAL TEAM RESTARTED THE TX ECO CABLE, RECONNECTION, AND THE CABLE REPLACEMENT DID NOT RESOLVE THE ISSUE. THE CATHETER WAS REPLACED WITH THE SECOND ONE, BUT ERROR 106 OCCURRED AGAIN. THE SAME MEASURES WERE PERFORMED AS FOR THE FIRST CATHETER, BUT THE ISSUE REMAINED. THE PHYSICIAN REQUESTED TO USE A D-CURVE CATHETER, AND THE CATHETER WAS REPLACED WITH SMART TOUCH SF CATHETER. THE ISSUE WAS RESOLVED. THEN, ABLATION WAS PERFORMED FROM WITHIN THE CORONARY SINUS TARGETING PVC (PREMATURE VENTRICULAR CONTRACTIONS) USING THERMOCOOL SMARTTOUCH SF CATHETER. SINCE THE PATIENT'S BLOOD PRESSURE WAS SLIGHTLY LOW AND PULSE ON FLUOROSCOPY WAS SLIGHTLY WEAK, AN ECHOCARDIOGRAPHY WAS PERFORMED AND A PERICARDIAL EFFUSION/CARDIAC TAMPONADE WAS CONFIRMED ABOUT 10 MINUTES AFTER THE FIRST ABLATION (TOTAL OF 4 ABLATIONS). DRAINAGE WAS PERFORMED AND THE P

  Patient problems: Cardiac Tamponade

  MAUDE report 24248448 ↗
• MalfunctionDec 29, 2025Failure to Sense; Manufacturing, Packaging or Shipping Problem; Failure to Sense; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. DURING THE PROCEDURE PREPARATION, THERE WAS AN ERROR INDICATING ¿106 FORCE CATHETER SENSOR ERROR¿ WHEN THE CATHETER WAS CONNECTED TO THE PATIENT INTERFACE UNIT (PIU). THE CONNECTING CABLE WAS REPLACED, AND BOTH THE WORKSTATION (WS) AND THE PIU WERE RESTARTED WITHOUT SOLVING THE PROBLEM. THE CATHETER GOT REPLACED AND THE CASE WENT ON WITH NO OTHER ISSUE. NO PATIENT CONSEQUENCE REPORTED. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 03-DEC-2025 REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A HOLE IN THE SURFACE OF THE PEBAX ON 03-DEC-2025 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23911266 ↗
• InjuryDec 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF, THE PATIENT EXPERIENCED AV-BLOCK 3RD GRADE. THE ADVERSE EVENT WAS NOT CONNECTED TO TECHNICAL ISSUES. THE ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. ABLATION TO CLOSE TO HIS/ATRIOVENTRICULAR NODE. THE INTERVENTION PROVIDED WAS TO WAIT. THE OUTCOME OF THE ADVERSE EVENT WAS UNCHANGED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION A PACEMAKER WAS NEEDED. THE ENERGY SOURCE USED WAS RADIOFREQUENCY. A SMARTABLATE GENERATOR AND PUMP WERE USED FOR THE PROCEDURE.

  Patient problems: Heart Block

  MAUDE report 23886624 ↗
• InjuryDec 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FRIBRILATION (PAF) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND THE PATIENT EXPERIENCED HEMOPERICARDIUM TREATED WITH REMOVAL OF 350ML VENOUS BLOOD AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT HEMOPERICARDIUM WAS DETECTED IN CARDIAC CONTROL ECHO AFTER THE PULMONARY VEIN ISOLATION (PVI) ON THE OPERATION TABLE. THE PATIENT¿S HEMODYNAMIC WAS STABLE. 350ML OF VENOUS BLOOD WAS EVACUATED (CONFIRMED BY BLOOD ANALYSIS). ACCORDING TO THE OPERATOR, THE HEMOPERICARDIUM AROSE BECAUSE OF A PUNCTURE OF THE ATRIAL SEPTAL, MAYBE HE PUNCTURED THE CORONARY SINUS. THE PATIENT IS NOW UNDER OBSERVATION IN THE INTENSIVE CARE UNIT. HEMODYNAMIC IS STABLE. THE OPERATION WAS FINISHED, THAT WAS THE PRIMARY ISOLATION OF THE PULMONARY VEINS. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED AND IT IS MOST LIKELY THAT IT WAS DAMAGED TO THE GREAT CARDIAC VEIN WHEN THE CORONARY SINUS (CS) CATHETER WAS INSERTED INTO THE CS O

  Patient problems: Cardiac Tamponade

  MAUDE report 23845482 ↗
• InjuryNov 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A LEFT IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND THE PATIENT EXPERIENCED BLOOD PRESSURE OF 72/51 AND PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS. IT WAS REPORTED THAT THERE WAS A PERICARDIAL EFFUSION REPORTED DURING PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION USING THE CARTO 3 SYSTEM AND THE THERMOCOOL SMARTTOUCH SF. WHILE BURNING IN THE ANTERIOR LATERAL PATH FOR A WHILE, THEY DID NOT NOTICE A CHANGE IN FORCE OR IMPEDANCE. THE PHYSICIAN THEN NOTICED THERE WAS A CHANGE IN THE PATIENT¿S NON-INVASIVE BLOOD PRESSURE. THE BLOOD PRESSURE WAS 72/51. A PERICARDIOCENTESIS WAS PERFORMED AND 40 ML OF FLUID WAS REMOVED. THE FLUID WAS GIVEN BACK TO THE PATIENT VIA A CENTRAL LINE. THE PATIENT¿S BLOOD PRESSURE IMPROVED AND THE EFFUSION "DID NOT COME BACK". THE PATIENT IS STABLE, AND THE DRAINAGE TUBE WAS REMOVED. THE PATIENT LEFT THE ELECTROPHYSIOLOGY (EP) LAB AND WAS TRANSPORTED TO THE CARDIOVASCULAR OUTPATIENT UNIT. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF STAYING OVERNIGHT FOR OBSERVATION ALTHOUGH NO EXTRA INTERVENTION OCCURRED. THE OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED (NO RESIDUAL EFFECTS).

  Patient problems: Cardiac Tamponade

  MAUDE report 23647313 ↗
• MalfunctionNov 20, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT ATRIAL FLUTTER (R-AFL) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND THERE WAS NO IRRIGATION FLOW DURING USE ON THE PATIENT. IT WAS INITIALLY REPORTED BY THE CUSTOMER THERE WAS A TEMPERATURE SPIKE ON THE THERMOCOOL SMARTTOUCH SF CATHETER AFTER THE ABLATION WAS STARTED AND THEN ABLATION STOPPED. THEY TOOK THE CATHETER OUT OF BODY, TRIED TO FLUSH; BUT THERE WAS NO FLOW. DISCONNECTED THE IRRIGATION TUBING FROM THE CATHETER AND CHECKED THE FLOW AND THERE WAS FLOW. THEY UNHOOKED PUMP, FLUSHED, THERE WAS FLOW, THEREFORE, THEY REPLACED CATHETER. THE CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. THE CATHETER WAS BELIEVED TO HAVE THE IRRIGATION PROBLEM. THERE WERE NO ERRORS ON THE NGEN PUMP, JUST THE TEMPERATURE TOO HIGH ON ABLATION. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR AND THERE WERE NO ISSUES WITH FLOW AT THE START OF ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610625 ↗
• InjuryNov 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  AFTER AND ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION (PE) WITH A DROP BLOOD PRESSURE. PATIENT WAS TREATED WITH PERICARDIOCENTESIS. AFTER THE CASE, A PERICARDIAL EFFUSION WAS NOTICED DURING A STANDARD POST PROCEDURE CHECK. NO ISSUES WERE REPORTED DURING THE PROCEDURE BUT AFTER THE PERICARDIAL EFFUSION WAS OBSERVED, THE PATIENT HAD A DROP IN BLOOD PRESSURE. PE WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN BELIEVES THE PERICARDIAL EFFUSION WAS RELATED TO THE TRANSSEPTAL PUNCTURE. IT WAS A DIFFICULT TRANSSEPTAL PUNCTURE AND THEY HAD TO DO IT TWICE DURING THE PROCEDURE. THEY ALSO HAD HIGH FORCE IN ONE AREA, BUT THE PHYSICIAN BELIEVES IT WAS DUE TO THE TRANSSEPTAL PUNCTURE. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THE PATIENT¿S OUTCOME FROM THE ADVERSE EVENT WAS IMPROVED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION. RELEVANT TESTS/LABORATORY DATA WAS ACT<350.

  Patient problems: Cardiac Tamponade

  MAUDE report 23522129 ↗
• MalfunctionOct 31, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN THERMOCOOL SMARTTOUCH SF AND A CATHETER SENSOR ERROR WAS NOTED. WHEN THE CABLE WAS SWITCHED OUT, THE ISSUE WAS NOT RESOLVED. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THERE WAS NO PATIENT CONSEQUENCE. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND SCREENING TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL ANALYSIS REVEALED A HOLE IN THE SURFACE OF THE PEBAX AND REDDISH MATERIAL INSIDE. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439592 ↗
• InjuryOct 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED BLOOD DRAWN /DRAINAGE. CARDIAC TAMPONADE OCCURRED. THE PHYSICIAN'S OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT SINCE IT WAS DURING THE TREATMENT OF CARDIAC TAMPONADE, AND UNABLE TO SPEAK DIRECTLY WITH THE PHYSICIAN. THE SECOND PHYSICIAN MENTIONED THAT THE EVENT WAS CAUSED BY THE PRIMARY PHYSICIAN¿S UNFAMILIARITY WITH THE CATHETER MANIPULATION AND DID NOT MENTION ABOUT THE EP PRODUCT. NO ABNORMALITIES OBSERVED PRIOR/DURING USE OF THE PRODUCT. NO EXTENDED HOSPITALIZATION. THE VISITAG COLORING SETTINGS WAS TAG INDEX. ADDITIONAL INFORMATION WAS RECEIVED ON 08-OCT-2025. IT WAS REPORTED THAT THE TIMING WAS AFTER THE PROCEDURE, WHEN CONFIRMING PERICARDIAL EFFUSION WITH AN ECHO, THE EXACT TIMING OF THE EVENT WAS UNCLEAR FOR EVERYONE, BUT BLOOD PRESSURE DECREASED SHORTLY AFTER THE RIGHT ATRIUM (RA) WAS ABLATED. BLOOD WAS DRAWN TO MANAGE THE SITUATION. THE PATIENT'S BLOOD PRESSURE RETURNED TO NORMAL. ADDITIONAL INFORMATION WAS RECEIVED ON 14-OCT-2025. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT

  Patient problems: Cardiac Tamponade

  MAUDE report 23404885 ↗
• InjurySep 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN IDVT (IDIOPATHIC VENTRICULAR TACHYCARDIA) ABLATION WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER, THE PATIENT LEFT THE EP (ELECTROPHYSIOLOGY) ROOM AND EXPERIENCED PERICARDIAL EFFUSION TREATED WITH DRAINAGE AND ISSUE WAS RESOLVED. IT WAS INDICATED THAT THE PHYSICIAN NOTICED IT WAS DIFFICULT TO MOVE THE CATHETER AROUND, AND THEY WERE HAVING "TROUBLE" GETTING SIGNALS. THERE WAS A "DROP" IN THE PATIENT¿S BLOOD PRESSURE, "FROM 130 TO 80S." ICE (INTRACARDIAC ECHOCARDIOGRAPHY) WAS USED TO CHECK AND THEY NOTICED A SLIGHT EFFUSION. THE PHYSICIAN PROCEEDED TO MANIPULATE THE CATHETERS AND "BURN" TO PUT IN TWO "RF" (RADIOFREQUENCY) ABLATIONS. THE PATIENT¿S BLOOD PRESSURE THEN DECREASED TO "50S." ICE WAS USED AGAIN TO CHECK, AND THE EFFUSION INCREASED IN SIZE. A PERICARDIOCENTESIS WAS PERFORMED AND THE EFFUSION WAS DRAINED BY REMOVING "450ML OF BLOOD FROM THE PERICARDIAL SPACE¿. WHILE DRAINING THE EFFUSION, THE PATIENT BLOOD PRESSURE GRADUALLY INCREASED. THE PATIENT¿S INJURY WAS IN THE "RVOT PERFORATION" (RIGHT VENTRICULAR OUTFLOW TRACT) WAS DISCOVERED BY THE EFFUSION AND CONFIRMED BY ICE AND X-RAY. AFTER THE PERICARDIOCENTESIS INTERVENTION, THE PATIENT WAS WA

  Patient problems: Cardiac Tamponade

  MAUDE report 23092180 ↗
• InjurySep 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND AT THE WARD AFTER THE PROCEDURE, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS WHICH REMOVED THE FLUID.

  Patient problems: Cardiac Tamponade

  MAUDE report 23041745 ↗
• InjurySep 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED DRAINAGE AND PROLONGED HOSPITALIZATION PRESENCE OF PERICARDIAL EFFUSION WAS CONFIRMED USING THE ECHOCARDIOGRAPHY. CONFIRMATION BY THE ULTRASOUND MACHINE WAS DONE AFTER THE ABLATION AND BEFORE HEMOSTASIS. DRAINAGE WAS PERFORMED AND THE SYMPTOMS IMPROVED. IT WAS CONFIRMED THAT THE PERICARDIAL EFFUSION WAS NOT RE-ACCUMULATING, THEN THE PATIENT LEFT THE ROOM. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION. DURING ABLATION, THERE WAS A MOMENT WHEN CONTACT FORCE WAS HIGH, BUT NO ABNORMAL BEHAVIOR OR DROPPING BLOOD PRESSURE WERE OBSERVED OTHERWISE. THE PHYSICIAN'S JUDGMENT ON HEALTH HAZARD WAS NONSERIOUS (MODERATE/MINOR). NO ABNORMALITIES WERE OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION RECEIVED INDICATES THE ADVERSE EVENT WAS FOUND AFTER THE ABLATION PHASE, BUT THE EXACT TIMING THAT THE EVENT OCCURRED WAS UNKNOWN. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT THE EXACT CAUSE IS UNKNOWN, BUT IT IS LIKELY DUE TO THE PROCEDURE. THE OUTCOME OF THE ADVERSE EVEN

  Patient problems: Cardiac Tamponade

  MAUDE report 23027700 ↗
• InjurySep 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER, THE PATIENT EXPERIENCED BLOOD PRESSURE DROPPED, AND PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS WITH REMOVAL OF 800CCS AND PROLONGED HOSPITALIZATION. INITIALLY, IT WAS REPORTED THAT BEFORE THE PROCEDURE BEGAN THE CARTO HAD A 1006 BACK PATCH SENSOR ERROR. THE GREEN AND YELLOW CABLE WERE SWAPPED, AND THE ISSUE FOLLOWED THE GREEN PATCH CABLE. IT WAS REPLACED AND THE ISSUE RESOLVED. THEN, AFTER A FEW ABLATIONS, THE PATIENT¿S BLOOD PRESSURE DROPPED. USING ULTRASOUND A PERICARDIAL EFFUSION WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 800ML OF FLUID WAS WITHDRAWN, AND THE PATIENT STABILIZED. NO FURTHER INTERVENTION WAS PLANNED POST PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS MAYBE THE RIGHT VENTRICLE (RV) CATHETER. THE PATIENT¿S OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS FULLY RECOVERED. THE PATIENT REQUIRED A FEW DAYS OF EXTENDED HOSPITALIZATION. THE ENERGY DELIVERED WAS RADIO FREQUENCY (RF). 4 CATHETER EXCHANGES OCCURRED DURING THE PROCEDURE. 6 TRANSSEPTAL P

  Patient problems: Cardiac Tamponade

  MAUDE report 22959987 ↗
• MalfunctionAug 19, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THERE WERE THREE THERMOCOOL SMARTTOUCH SF CATHETERS WITH PERFORATED PRIMARY PACKAGING AS THE PRODUCT LOSES STERILITY. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THERE WAS NO DETECTION MADE UPON RECEIPT OF THE PRODUCT. THE THREE THERMOCOOL SMARTTOUCH SF CATHETERS WERE ASSESSED AS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841178 ↗
• MalfunctionAug 19, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THERE WERE THREE THERMOCOOL SMARTTOUCH SF CATHETERS WITH PERFORATED PRIMARY PACKAGING AS THE PRODUCT LOSES STERILITY. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THERE WAS NO DETECTION MADE UPON RECEIPT OF THE PRODUCT. THE THREE THERMOCOOL SMARTTOUCH SF CATHETERS WERE ASSESSED AS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840984 ↗
• MalfunctionAug 19, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THERE WERE THREE THERMOCOOL SMARTTOUCH SF CATHETERS WITH PERFORATED PRIMARY PACKAGING AS THE PRODUCT LOSES STERILITY. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THERE WAS NO DETECTION MADE UPON RECEIPT OF THE PRODUCT. THE THREE THERMOCOOL SMARTTOUCH SF CATHETERS WERE ASSESSED AS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840460 ↗
• InjuryJul 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIAL DRAINAGE AND PROLONGED HOSPITALIZATION. ABLATION WAS PERFORMED AS USUAL, AND THERE WAS ALMOST NO PERICARDIAL EFFUSION IMMEDIATELY AFTER THE PROCEDURE, ALLOWING THE PATIENT TO RETURN TO THE ROOM. LATER THAT NIGHT, A DECREASE IN BLOOD PRESSURE WAS OBSERVED AND PERICARDIAL EFFUSION WAS CONFIRMED. THEY WAITED UNTIL MORNING TO PERFORM PERICARDIUM PUNCTURE (APPROXIMATELY 500 ML OF BLOOD WAS DRAINED). THE SPECIFIC TIMING AND DATES INCLUDE: ON JUNE 30, ABLATION WAS PERFORMED. THAT NIGHT, A DECREASE IN BLOOD PRESSURE AND PERICARDIAL EFFUSION WERE OBSERVED. ON JULY 1 AT 9 AM, PERICARDIUM PUNCTURE WAS PERFORMED. THE PATIENT RECOVERED, HOWEVER, REQUIRED EXTENDED HOSPITALIZATION. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT IS THAT THERE WERE NO ACTIONS DURING THE ABLATION THAT WOULD CAUSE TAMPONADE. NO ABNORMALITIES WERE OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT TH

  Patient problems: Cardiac Tamponade

  MAUDE report 22596569 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030031. One submission often covers many models, so check the product and lot details in each record.

• Z-0169-2023 · Sep 7, 2022 · Open, Classified
  THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in con
• Z-0139-2015 · Oct 19, 2014 · Terminated
  ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
• Z-0983-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0981-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0979-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0980-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0982-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0057-06 · Aug 8, 2005 · Terminated
  Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R P